Phase-I of the GMP-compliant purified water (PW) system is now fully operational at the company's Bavla CDMO site, supplying four production units to 100% microbiological and chemical compliance.
Gujarat, INDIA (September 2026) – Ahmedabad-based Dishman Carbogen Amcis Ltd, a global contract development and manufacturing organization (CDMO), has successfully completed Phase-I of its new Purified Water (PW) generation and distribution system at its Bavla manufacturing site in Gujarat, India. The system, engineered and supplied by BWT Switzerland — the same technology partner that serves Carbogen Amcis Switzerland — is now in continuous operation, supplying Units 1, 2, 6 and 6B. It has been independently recognized by CN-BWT as the largest purified water installation commissioned at any pharmaceutical manufacturing site in India to date.
Why Purified Water Systems Matter for CDMO and Pharmaceutical Manufacturing
In pharmaceutical manufacturing, purified water is a critical raw material and utility, used across API synthesis, formulation, equipment cleaning, and sanitization. For a CDMO running multiple production units under one quality umbrella, the reliability, capacity, and regulatory compliance of the purified water system directly affect manufacturing uptime, batch release timelines, and client audit outcomes. The new system at Bavla was engineered to meet these demands at scale, supporting current API and formulation output while building in headroom for future site expansion.
Engineering Scale and Automation for High-Volume CDMO Operations
Designed for a generation capacity of up to 144 kilolitres per day, the purified water plant is connected via a piping network exceeding 8 kilometres in length. This extensive network is sized not only for present requirements but also to accommodate future site expansion without the need for structural rework.
The entire operation is governed by a centralized control system with full interlock integration, enabling automated, closed-loop management across the generation and distribution loops. This sophisticated automation minimizes manual intervention points, significantly reducing the risk of contamination—a critical factor for any GMP-compliant pharmaceutical manufacturing infrastructure.
Multi-Stage Purification Train Ensures Pharma-Grade Water Quality
Water quality is maintained through a multi-stage treatment train, each stage targeting a specific class of contaminant:
- Bewazon — pre-treatment microbial control
- Osmotron — conductivity control via reverse osmosis
- Septron — electrodeionization (EDI) combined with ultrafiltration
- Steritron — final microbial control
- Online TOC monitoring — continuous verification of total organic carbon
This staged architecture allows each critical quality parameter — bioburden, conductivity, endotoxin-related organics, and total organic carbon — to be controlled and monitored independently, rather than relying on a single point of control. Since commissioning, Phase-I has demonstrated 100% compliance with all microbiological and chemical acceptance criteria, delivering consistent pharma-grade water quality across every connected production unit.
GMP, 21 CFR and GAMP-5 Compliance for Regulatory-Ready CDMO Manufacturing
The purified water system is managed under a compliance framework aligned to 21 CFR Part-11, GAMP-5, ASME, and DIN standards, supporting both regulatory audit readiness and long-term data integrity. For a CDMO serving global pharmaceutical clients, this level of documented, standards-based compliance is a prerequisite for client qualification audits and regulatory inspections across multiple markets.
Sustainable Water Treatment Supports ESG Goals in Pharmaceutical Manufacturing
A key differentiator of this system is its sanitization method. Sanitization across the network is performed using ozone rather than the traditional hot-water sanitization cycles commonly found in ordinary setups. This innovative approach offers significant sustainability and operational advantages:
- Reduced Energy Consumption: Ozone sanitization requires less energy compared to heating large volumes of water.
- Shorter Cycle Times: The process is faster, improving overall system efficiency.
- Zero Water Waste: Critically, the water used in ozone sanitization remains usable after the cycle. In stark contrast, traditional hot-water sanitization requires the water to be drained and discarded, placing a significant load on the Effluent Treatment Plant (ETP). This new approach eliminates water loss, reduces ETP burden, and contributes directly to the site's broader ESG and sustainable manufacturing objectives.
A Milestone for CDMO Capacity and Quality at the Bavla Site
Taken together, the capacity, redundant purification architecture, and centralized automation make this system a world-class utility platform for the Bavla site — one built to support current manufacturing demand while remaining ready for future growth. The successful completion of Phase-I reflects sustained cross-functional coordination, and the Engineering department's contribution to delivering a system of this scale and complexity has been central to its success.
Frequently Asked Questions
What is a purified water (PW) system in pharmaceutical manufacturing?
A purified water system generates and distributes water that meets pharmacopoeial quality standards, such as USP and Ph. Eur., for use in non-parenteral pharmaceutical manufacturing, including formulation, equipment cleaning, and rinsing.
Why is GMP-compliant purified water important for CDMOs?
CDMOs manufacture on behalf of multiple pharmaceutical clients, so consistent, GMP-compliant water quality directly affects batch compliance, client audits, and regulatory approvals across every program run through the facility.
What standards does the Bavla purified water plant comply with?
The system is managed under a compliance framework aligned to 21 CFR Part-11, GAMP-5, ASME, and DIN standards, and has demonstrated 100% compliance with all microbiological and chemical acceptance criteria since commissioning.
How does ozone sanitization support sustainable pharmaceutical manufacturing?
Ozone-based sanitization reduces energy use and cycle time compared with heat- or chemical-based methods, and eliminates the water loss typically associated with hot-water sanitisation, directly supporting site-level ESG targets.
